A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Platinum Plus Pemetrexed Chemotherapy Plus Osimertinib Versus Platinum Plus Pemetrexed Chemotherapy Plus Placebo in Patients with EGFRm, Locally Advanced or Metastatic NSCLC who have Progressed Extracranially following First-Line Osimertinib Therapy (COMPEL) - COMPE

ASTRAZENECA AB0 个研究点目标入组 204 人开始时间: 2021年6月8日最近更新: 2024年1月8日

适应症

试验速览

暂无简介。

•1) Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
•2) Pathologically confirmed non-squamous NSCLC (Non-small cell lung cancer )
•3) Locally advanced (clinical stage IIIB or IIIC) or metastatic NSCLC (clinical stage IVA or IVB) or recurrent NSCLC, not amenable to curative surgery or radiotherapy.
•4) Evidence of radiological extracranial disease progression following response with first line osimertinib treatment but who have not received further, subsequent treatment.
•5) World Health Organization performance status of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks.
•6) Life expectancy >12 weeks at Day 1.
•7) At least 1 lesion, not previously irradiated.
•8) Females must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of child-bearing potential, or must have evidence of non-child-bearing potential by fulfilling criteria at screening.
•9) Male patients must be willing to use barrier contraception
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 122
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 82

•- Clinical or radiological evidence of CNS progression on first-line osimertinib
•- Past medical history of ILD/pneumonitis, drug-induced ILD/pneumonitis, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD/pneumonitis
•- Any concurrent and/or other active malignancy that has required treatment within 2 years of first dose of IP
•- Any unresolved toxicities from prior extracranial therapy (eg, adjuvant chemotherapy) greater than CTCAE Grade 1 at the time of starting IP, with the exception of alopecia and Grade 2 prior platinum-therapy related neuropathy.
•- More than 4 weeks elapsed since last dose of osimertinib by date of randomization

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